NCT00942331 · BASELINE
Baseline characteristics
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- denoms
- counts
- group Id
- BG000
- value
- 252
- group Id
- BG001
- value
- 254
- group Id
- BG002
- value
- 506
- units
- Participants
- groups
- description
- Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
- id
- BG000
- title
- Arm II (GCB)
- description
- Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
- id
- BG001
- title
- Arm I (GCP)
- description
- Total of all reporting groups
- id
- BG002
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 24
- upper Limit
- 83
- value
- 64
- group Id
- BG001
- lower Limit
- 25
- upper Limit
- 83
- value
- 63
- group Id
- BG002
- lower Limit
- 24
- upper Limit
- 83
- value
- 63
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 53
- group Id
- BG001
- value
- 56
- group Id
- BG002
- value
- 109
- title
- Female
- measurements
- group Id
- BG000
- value
- 199
- group Id
- BG001
- value
- 198
- group Id
- BG002
- value
- 397
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 7
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 13
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 18
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 229
- group Id
- BG001
- value
- 235
- group Id
- BG002
- value
- 464
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 7
- group Id
- BG001
- value
- 10
- group Id
- BG002
- value
- 17
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 146
- group Id
- BG001
- value
- 132
- group Id
- BG002
- value
- 278
- title
- 0
- measurements
- group Id
- BG000
- value
- 106
- group Id
- BG001
- value
- 122
- group Id
- BG002
- value
- 228
- title
- 1
- description
- Eastern Cooperative Oncology Group PS Scale: 0)Fully active, able to carry on all pre-disease performance without restriction; 1)Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2)Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; 3)Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4)Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.
- param Type
- COUNT_OF_PARTICIPANTS
- title
- ECOG Performance Status
- unit Of Measure
- Participants
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 252
- group Id
- BG001
- value
- 254
- group Id
- BG002
- value
- 506
- units
- Participants
- groups
- description
- Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
- id
- BG000
- title
- Arm II (GCB)
- description
- Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
- id
- BG001
- title
- Arm I (GCP)
- description
- Total of all reporting groups
- id
- BG002
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 24
- upper Limit
- 83
- value
- 64
- group Id
- BG001
- lower Limit
- 25
- upper Limit
- 83
- value
- 63
- group Id
- BG002
- lower Limit
- 24
- upper Limit
- 83
- value
- 63
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 53
- group Id
- BG001
- value
- 56
- group Id
- BG002
- value
- 109
- title
- Female
- measurements
- group Id
- BG000
- value
- 199
- group Id
- BG001
- value
- 198
- group Id
- BG002
- value
- 397
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 7
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 13
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 18
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 229
- group Id
- BG001
- value
- 235
- group Id
- BG002
- value
- 464
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 7
- group Id
- BG001
- value
- 10
- group Id
- BG002
- value
- 17
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 146
- group Id
- BG001
- value
- 132
- group Id
- BG002
- value
- 278
- title
- 0
- measurements
- group Id
- BG000
- value
- 106
- group Id
- BG001
- value
- 122
- group Id
- BG002
- value
- 228
- title
- 1
- description
- Eastern Cooperative Oncology Group PS Scale: 0)Fully active, able to carry on all pre-disease performance without restriction; 1)Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2)Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; 3)Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4)Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.
- param Type
- COUNT_OF_PARTICIPANTS
- title
- ECOG Performance Status
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice
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